Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Cataract; High Myopia

Treatments: Procedure: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy); Procedure: Enhanced monofocal intraocular lens implantation (monovision strategy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07168109

2025KYPJ072

Details and patient eligibility

About

The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial length ≥ 26 mm).

The main questions it aims to answer are:

For people with cataract and high myopia, does an enhanced monofocal intraocular lens targeted for monovision provide greater binocular uncorrected distance visual acuity compared with targeting myopia in both eyes? Does an enhanced monofocal intraocular lens targeted for monovision provide comparable binocular uncorrected intermediate and near visual acuity, contrast sensitivity, reading ability, spectacle independence, stereopsis, and photic phenomena compared with targeting myopia in both eyes?

Researchers will compare an enhanced monofocal intraocular lens targeted for monovision with one targeted for myopia in both eyes to determine whether the monovision strategy is more effective.

Participants will:

Undergo phacoemulsification with enhanced monofocal intraocular lens implantation. Attend follow-up visits at 1, 3, 6, and 12 months after cataract surgery.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 85 years (inclusive), no gender restrictions;
2. Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
3. Axial length ≥ 26.0 mm in both eyes;
4. Desire for postoperative spectacle independence;
5. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.

Exclusion criteria

1. Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
2. Preoperative corneal astigmatism ≥ 1.5 diopters (D);
3. Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
4. The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
5. A history of intraocular surgery;
6. Severe chronic systemic diseases, psychiatric disorders, dementia, hearing impairments, or mobility limitations that would interfere with understanding of the monovision design, attendance at follow-up visits, or completion of questionnaires.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Monovision group

Experimental group

Description:

Both eyes will be implanted with enhanced monofocal intraocular lenses, with the dominant eye targeted for -0.5 diopters (D) and the nondominant eye for -2.0 D.

Treatment:

Procedure: Enhanced monofocal intraocular lens implantation (monovision strategy)

Bilateral myopia group

Active Comparator group

Description:

Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D.

Treatment:

Procedure: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)